A Study to Investigate the Anti-Plaque Effect of AN0128 Toothpaste

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00762151

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study was to evaluate the anti-plaque efficacy of the Anacor prototype dentrifice as compared to commercial control products following a single use of the dentrifice.

Condition or Disease	Intervention/Treatment	Phase
Dental Plaque	Other: Negative Control (Regular Toothpaste) Other: Positive Control (anti-plaque/anti-bacterial toothpaste) Drug: Prototype (AN0128 Toothpaste)	Phase 1

Detailed Description

The widespread successful use of triclosan as an anti-inflammatory and anti-bacterial agent is well documented. The standard dentrifice has demonstrated a robust anti-plaque and anti-inflammatory effect providing multiple benefits. There is a clear value to identify additional agents with the same dual action with a comparable or an enhanced level of efficacy. This study examined the anti-plaque efficacy following a single use of the prototype dentifrice.

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Clinical Research Study to Investigate the Anti-Plaque Effect of a Prototype Toothpaste Containing an Anacor Material Via the MGMPI Method

Study Start Date :

Nov 1, 2007

Actual Primary Completion Date :

Jan 1, 2008

Actual Study Completion Date :

Jan 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Negative Control Regular Toothpaste	Other: Negative Control (Regular Toothpaste) Regular Toothpaste
Active Comparator: Positive Control Standard anti-plaque and anti-bacterial toothpaste.	Other: Positive Control (anti-plaque/anti-bacterial toothpaste) Standard anti-plaque and anti-bacterial toothpaste
Active Comparator: Prototype AN0128 Toothpaste	Drug: Prototype (AN0128 Toothpaste) AN0128 Toothpaste

Arm

Intervention/Treatment

Placebo Comparator: Negative Control

Regular Toothpaste

Other: Negative Control (Regular Toothpaste)

Regular Toothpaste

Active Comparator: Positive Control

Standard anti-plaque and anti-bacterial toothpaste.

Other: Positive Control (anti-plaque/anti-bacterial toothpaste)

Standard anti-plaque and anti-bacterial toothpaste

Active Comparator: Prototype

AN0128 Toothpaste

Drug: Prototype (AN0128 Toothpaste)

AN0128 Toothpaste

Outcome Measures

Primary Outcome Measures

Reduction in the gingival margin plaque index in a 24-hour post-treatment (no brushing) [Baseline (time zero), 24 hour time point]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Must be between ages 18 to 65 years inclusive
Have a minimum of 16 natural uncrowned teeth (excluding 3rd molars) present
Must give written informed consent
Be in good general health
Must discontinue oral hygiene for 24-hours after initial appointment
No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study

Exclusion Criteria:

Medical condition which requires pre-medication prior to dental visits/procedures
Advanced periodontal disease
5 or more decayed, untreated dental sites
Diseases of the soft or hard oral tissues
Orthodontic appliances
Abnormal salivary function
Use of drugs that can affect salivary flow
Use of antibiotics one (1) month prior to or during this study
Use of any over the counter medications other than analgesics (i.e. aspirin, ibuprofen, acetaminophen, naproxen), unless approved by the study medical staff
Pregnant or breastfeeding
Participation in another clinical study in the month preceding this study
Allergic to common dentifrice ingredients
Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
History of allergic reaction to any anti-inflammatory agents

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Concordia Research Laboratories	Cedar Knolls	New Jersey	United States	07927

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT00762151

Other Study ID Numbers:

AN0128 Periodontal Plaque

First Posted:

Sep 30, 2008

Last Update Posted:

Jun 5, 2019

Last Verified:

Jun 1, 2019

Keywords provided by Pfizer

Dental Plaque

Additional relevant MeSH terms:

Dental Plaque

Anti-Bacterial Agents

Study Results

No Results Posted as of Jun 5, 2019